Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1

NCT04158908 | Completed Results DMC

• 2 other identifiers: 19-07020392-Phase1R21NR018693-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

When advanced disease progresses, there comes a time when an oncologists must explain to their patients that they only have months left to live. During these discussions the oncologist attempts to explain to the patient their prognoses and what it means for them going forward. However the investigator's prior studies shown that even when patients only have months left to live, most do not understand that their cancer is incurable and that it is late/end-stage. Dying cancer patients who fully understand their prognosis are able to make more informed decisions and are therefore more likely to engage in advanced care planning, and receive care what in consistent with their values and preferences. They are also in a better position to avoid burdensome, non-beneficial care. The investigator developed Oncolo-GIST in order to help increase the number of patients who fully understand their prognosis and its implications. Oncolo-GIST is an intervention aimed at enhancing clinicians' communication with patients by teaching them to relay information both sensitively and using simple terminology. The Oncolo-GIST training will provide instruction in areas such as how to introduce the topic of prognosis (describe scan results as "worse"), how to phrase the prognosis itself ("likely months, not years"), how to explain expected treatment outcomes (e.g., "not expected to be cured by treatment") and how to describe expected treatments impact on quality of life - that is, whether the anticancer treatment is likely to make them feel overall better or worse. The training materials consist of a manual and a set of videos that act out situations described in the manual. The first phase of this study will consists of two parts:

1. 1.Stakeholder Interviews: The investigator will obtain feedback from relevant stakeholders/key informants on Oncolo-GIST Version 1.0 manual and videos using a version of the Delphi method in which the investigator will interview bereaved family caregivers of advanced cancer patients (n=10) and oncology clinicians who care for patients with advanced gastrointestinal (GI) and thoracic (lung) cancers (n=10). The information gathered will be used to develop Oncolo-GIST Version 2.0.
2. 2.Open Trial: The investigator will conduct an initial open trial of the Oncolo-GIST intervention to 10 advanced cancer patients (N=10) by participant clinicians (n=8). This will help us gather information about the feasibility and acceptability of the intervention to patients and oncologists and also inform changes for Oncolo-GIST Version 2.0.

Conditions

Critical Illness; Oncology; Communication

Outcome Measures

Primary Outcomes (4)

• Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers

  Acceptability will be determined by requesting and comparing caregivers' responses to the specific phrasings indicated in the Oncolo-GIST manual for oncologists, with regard to sensitivity and comprehensibility.

  From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.

• Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians

  Acceptability will be determined by requesting and comparing a range of clinicians' responses to the specific phrasings indicated in the Oncolo-GIST manual, with regard to sensitivity, comprehensibility, and accordance with the principles of informed consent.

  From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.

• Feasibility of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians

  Feasibility will be determined by requesting and comparing clinicians' responses to the manual's format and content, to determine the extent to which it is implementable in a clinical setting.

  From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.

• Potential Improvements to the Oncolo-GIST Manual According to Structured Qualitative Surveys

  Using a version of the Delphi method 14, the responses of caregivers and clinicians will be anonymously amalgamated and compared in order to identify common criticisms of or suggestions for the manual, by frequency or priority, which can be implemented in Oncolo-GIST 2.0.

  From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.

Study Arms (2)

Oncolo-GIST Arm: Caregivers

Caregiver stakeholders were bereaved family members of a patient who had died from solid tumor cancer in the past year. Stakeholders reviewed an initial version of the Oncolo-GIST manual to provide feedback and refine the manual for Phase 2.

Behavioral: Oncolo-GIST

Oncolo-GIST Arm: Clinicians

Clinician stakeholders were physicians, nurses, nurse practitioners, and social workers with expertise in treating advanced cancer patients. Stakeholders reviewed an initial version of the Oncolo-GIST manual to provide feedback and refine the manual for Phase 2.

Behavioral: Oncolo-GIST

Interventions

Oncolo-GIST BEHAVIORAL

Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information. Topic covered include: 1. Principles of introducing prognosis in the setting of worsened scan results 2. Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") 3. Addressing informational needs and psychological reactions 4. Applying proven techniques for supporting patients who are reluctant to discuss prognosis. The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.

Oncolo-GIST Arm: Caregivers; Oncolo-GIST Arm: Clinicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caregivers were selected from among families of past patients identified by clinicians at Weill Cornell Medicine. Clinicians with expertise in palliative medicine were selected from among colleagues of PI.

You may qualify if:

• Currently care for patients with metastatic GI and lung cancers as an oncologist, palliative care physician, nurse, nurse practitioner, social worker, or psychologist

You may not qualify if:

• Does not currently care for patients with metastatic GI and lung cancers as either an oncologist, palliative care physician, nurse, nurse practitioner, social worker, or psychologist
• Caregivers (Stakeholder Interviews)
• Caregivers of patients who died in the past year with a primary diagnoses of GI or lung cancer
• Caregivers of patients who died longer than 1 year from the time of enrollment
• Caregivers of a patient that did not have a primary diagnoses of GI or lung cancer
• Not fluent in English
• Clinicians (Open Trial)
• Specialize in Lung and GI cancers
• Currently provide care at the WCM Lung and GI cancer clinics
• Fluent in English
• Does not specialize in Lung and GI cancers
• Does not currently provide care at the WCM Lung and GI cancer clinics
• Not fluent in English
• Patients (Open Trial)
• Receiving ongoing care (≥ 2 visits) that includes regular scans

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Related Publications (45)

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MeSH Terms

Conditions

Critical Illness; Neoplasms; Communication

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

Two participants (one clinician, one stakeholder) were unable to complete the study due to difficulties caused by COVID-19. In addition, racial and ethnic diversity among stakeholders was limited, which may have limited the study's ability to capture important cultural perspectives. Additionally, only three male caregivers participated.

Results Point of Contact

• Title: Sophia Kakarala
• Organization: Weill Cornell Medicine

sok4004@med.cornell.edu

(646) 962-5650

Study Officials

• Holly G Prigerson, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: January 17, 2020
• Primary Completion: April 16, 2020
• Study Completion: July 29, 2020
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)